Neuropsychiatrics disease in general in particular for affective disorders such as anxiety and depression Neuropsychiatric diseases
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Healthy, male and female subjects between 25-65 of age, inclusive. For cohort 2: between 40 and 75 years of age, inclusive. - Female participants must be postmenopausal or must be on hormonal contraception for at least 6 months regulating the menstrual cycle. - Subjects must have a BMI between > 18.0 and 30.0 kg/m2, inclusive (BMI*
Exclusion criteria
Exclusion criteria: - Pregnant woman. - Past or present history of any clinically relevant psychiatric disorder as classified according to DSM-IV or DSM 5, mood, anxiety and psychotic disorders in particular. - Subject has a history of drug or alcohol use disorder according to DSM-IV or DSM 5 within 12 months before screening or has a positive test result(s) for alcohol and/or drugs of abuse (including but not limited to: opiates (including methadone), cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, and benzodiazepines) at screening or admission to the clinical unit. - Significant coagulation abnormality (e.g. hemophilia, platelet counts less than the lower limit of normal or clinically significant elevation in PT or PTT at screening), or has a medical condition requiring treatment with an anticoagulant (e.g. warfarin) or with two or more antiplatelet agents. Platelet counts between 125,000 and 150,000/microliter are permissible as long as the investigator confirms there is no evidence of current bleeding diathesis or coagulopathy. - Subject has abnormalities upon fundoscopy indicating an increased Intracranial Pressure (ICP), unless assessed as safe by principal investigator when no further evidence is present indicating ICP. - History of clinically significant back pathology and/or back injury (e.g. degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with the spinal catheter.* - Subject smokes cigarettes (or equivalent) and/or has used nicotine-based products within 3*months prior to spinal catheter insertion ; positive cotinine test at screening and admission. - Subject has a history of heparin allergy. - Subject has undergone major lifestyle changes in the previous 6 months: significant weight loss > 5kg or started a specific diet which could potentially result in weight loss. - Vulnerable subjects (e.g., a person kept in detention or a person under guardianship). - Subject is unable to read and understand the consent forms, complete study-related procedures, and/or communicate with the study staff. - Unsuitable veins for cannulation and/or repeated venepuncture. - Diagnosis or suspicions of any sleep disorder in the last 6 months or current complaints of sleep disturbance, irregular sleep schedule or shift work; habitual daytime naps; travel across time zones in the last 4 weeks or daytime symptoms attributable to unsatisfactory sleep. - Use of a prescription medicine and or over-the-counter medicine influencing the sleeping habits (such as benzodiazepines, melatonin) or occasional use (last 6 months) of cannabis (in all its forms including the use of cannabidiol (CBD)).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * CSF and plasma 2-AG * CSF and plasma 1-AG | — |
Secondary
| Measure | Time frame |
|---|---|
| * CSF and plasma 2-AG and 1-AG * CSF BDNF * plasma ACTH * serum cortisol * serum prolactin * sleep duration, sleep onset and time to wake * sleep cycles: deep, light, REM phases * BMI * total body fat | — |
Countries
Netherlands
Outcome results
None listed